Now FDA's device office has published priorities that sets its sights for the next three years. The three specific goals in the document are to:
"Lean," or streamline, at least 80% of CDRH's core processes; Achieve at least an 80% "employee engagement" level at the center; and Help establish at least 10 new "collaborative communities" that incorporate a range of stakeholders.
Shuren said these should translate to more novel devices entering the US market due to reduced regulatory burdens for manufacturers, improved retention of high-quality staff at the center by giving them more opportunities to advance, and the development of more public-private partnership organizations that allow industry, FDA and other stakeholders to better communicate about bringing products to market faster and smoother.
The new set of priorities originated when the center "reset its North Star" in 2012 to focus on getting novel medical devices to patients in the US first, Shuren told Medtech Insight. Historically, medical devices, particularly new novel devices, have been introduced first in Europe and other markets under a CE mark well before they could get through FDA to enter the US market due to higher regulatory demand.
The device center has made a shift in recent years, including reforms to speed up the launch of device clinical trials in the US and finding opportunities for companies to shift more of their data burden from the pre-market to post-market phase.
"Over the past five years our strategic priorities have been focused on reducing the time and cost across the total product lifecycle such that innovators view the marketplace more favorably, but not sacrifice that standard of reasonable assurance of safety and effectiveness," said Shuren.
The director says now that the center has put the foundation in place, the three strategic priorities laid out in the latest document are intended to make that vision a reality.
A priority for the center is to help simplify all the work CDRH does. The goal is to find ways to simplify core processes to reduce unnecessary burdens on CDRH staff and stakeholders, including device companies.
"Simplicity means that in everything we do, we continually streamline our policies, processes, programs, and approaches, as appropriate, to more effectively, efficiently, and quickly achieve our mission and vision," states CDRH. "It means we stop doing, or streamline what we determine is not sufficiently 'value added' to the regulatory process, and free our CDRH team to spend more time on what matters most to patients and staff."
Part of this will include developing decision aids that can help make its policies more straightforward and give stakeholders more confidence that decision outcomes will be similar regardless of who is applying the policy. The center also wants to remove cumbersome processes, vague policies and out-of-date information technology systems that don't add significant benefit to its work.
The goal is for the simplicity principle permeate all CDRH does over the next three years, including in its review processes, guidances and rules. The center also believes the approach aligns with its efforts in conjunction with the International Medicare Device Regulators Forum (IMDRF) to globally harmonize, including the longer-term goal of a Medical Device Single Review Program that could allow a product to enter multiple markets based on a single-review process.
Collaborative Communities, On A Global Scale
Over the past few years, CDRH has been bringing industry, researchers and patient advocacy groups to the table to reach consensus about important issues related to the medtech landscape. One such group that has spawned from these talks is the Medical Device Innovation Consortium, or MDIC. The group has been instrumental in helping FDA develop guidance on using patient preference information to support certain medical devices coming to market, as well as developing new research tools that could be used to show the safety and efficacy of products based on less data.
FDA's device center says it wants to build on this type of effort and establish more collaborative communities to reach consensus and solutions.
Over the next three years CDRH says it will make building Collaborative Communities a standard practice. The center says it will also consider whether it can take that approach and adopt it across borders.
"In addition, we will consider whether a Collaborative Community approach could be adopted across two or more countries," said the center. "IMDRF, whose mission is to advance the convergence and harmonization of medical device regulation, and of which the US is a cofounder and active member, could serve as a catalyst for the establishment of global Collaborative Communities."
CDRH hopes that over the next three years it will be able to help develop at least 10 more collaborative communities that can help bring FDA and other stakeholders to the table to talk about a wide range of issues.
Over the past few years, Shuren has been almost on a crusade to get more funding for CDRH staff. The director has bemoaned the high turnover at the center and struggles to find qualified staff willing to come work for him instead of industry. However, over the past year, with passage of the 21st Century Cures Act and latest device user-fee deal, MDUFA IV, there has been a significant boost to the center's funding to help make it more salary-competitive.
Shuren hopes this will mean he will be able to not just hire qualified staff, but also retain them.
One part of this effort is establishment of new cross-cutting office, which will be called the Office of Product Evaluation and Quality, to replace the Office of Device Evaluation, Office of Compliance, and Office of Surveillance and Biometrics. (Also see "'Super Office' To The Rescue: FDA's Device Center Is About To Undergo A 'Total Product Life Cycle' Makeover" - Medtech Insight, 29 Sep, 2017.) With that reorganization, CDRH is looking to give its officials more flexibility to not just become experts on products over their lifecycle, but also to grow in their career tracks.
"Over the next three years we will complete our efforts to make the CDRH workplace one of trust, mutual respect and accountability, ongoing and open dialogue, and personal and professional growth," states CDRH. "Our own research and results of the 2017 Federal Employee Viewpoint Survey show that over 70% of our workforce is engaged and our turnover rates best those in much of the public and private sectors, but we know we can – and we commit that we will – do better.
"Our employees deserve no less than a best-in-class work life and work environment, and the American public deserve no less than a fully engaged, best-in-class workforce," it adds.